Posted from: Thursday, March 07, 2019 - 10:39 AM - Present

Zovirax Generic Approved

February 4, 2019 – The U.S. FDA has approved Perrigo’s generic for GlaxoSmithKline’s Zovirax® (acyclovir) Cream 5%. Perrigo’s generic is the first FDA-approved generic for Zovirax, and was developed in collaboration with Sol-Gel Technologies.

Acyclovir cream is approved to treat recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older. Treatment should begin as soon as possible following the first signs or symptoms of a cold sore. Recommended dosing lasts four days, with cream applied five times per day at the affected site. 

Zovirax Cream received FDA approval in 2002. Generics for a different dosage form, Zovirax Ointment, have been available from multiple manufacturers since 2013. Perrigo launched its acyclovir cream in February at an average wholesale price (AWP) of $911.84, compared to an AWP of $1,013.15 for the name brand.

Last Updated Friday, October 18, 2019 - 12:48 AM.